Medical Innovation Bill and cannabis

..sent to clients 18 Dec… Dr Narend Singh who took over the tabling of the Private Members’ Medical Innovation Bill from the late Dr Mario Ambrosini, said that he was so impressed by the progress of the Department of Health (DHA) in their support of the use of cannabis for medical purposes that he could see the possibility arising where he could withdraw his Members’ Bill in favour of broader legislation tabled by the Minister of Health.

He said “there was light at the end of the tunnel” and he himself was on a “high” to learn from Dr Joey Gouws, in charge of regulatory and legislative enforcement at DHA, that regulations on the growing of cannabis, manufacture, dispensing and medical use for medicinal purposes could be in place by the end of 2017 including registration processes and classification systems.

Holistic approach

Dr Gouws was briefing the Parliamentary Portfolio on Health on progress towards the commencement of such a programme and which not only covered the medical use of cannabis as proposed in the Medical Innovation Bill but covered research, registration, manufacture and the scheduling of substances. Separate legislation would be in parallel amending such Acts as the Drugs and Drugs Trafficking Act.

Regulations were a draft form stage in authorising permits for use by practitioners, analysts, researchers or veterinarians. In fact, said the DHA team presenting the update to parliamentarians, it might be possible to see certain herbal products with limited THC levels available within three months.

Worldwide

Dr Gouws said that in the United Kingdom similar legislation, to be enacted, provided for innovation in medical treatment and allowed medical doctors to depart from medical treatments for a condition but the UK Bill did not specially address the use of cannabis. In South Africa, it will be allowed for under specific prescribed conditions for the treatment of certain medical conditions and for education, research and analysis. Similar legislation in Australia and Canada had been studied.

Patients that are proposed for eligibility are those with severe pain, nausea, vomiting or wasting arising from cancer and HIV/AIDS, including treatment. Muscle spasms and severe pain associated with multiple sclerosis and seizures from epilepsy where other treatment options have failed or have intolerable side effects. Severe chronic pain is included as part of the proposals for indications.

Crop trials completed

The Department of Agriculture, the DHA team said, has just forwarded the outcome of cultivation trials at four agricultural research facilities jointly overseen by both departments. This would now be disseminated and assessed, which results would form part of the ongoing research by the Medical Research Council and other academic research centres involved in the future clinical use of cannabis.

Currently, cannabis is listed as a Schedule 7 prohibited substance but regulations will shift this towards Schedules 3-6 which are prescription-only medicines with authorised prescribers. Scheduling decisions involve levels of toxicity and safety; the proposed indication for a substance; the need for medical diagnosis before prescribing; the potential for dependence, abuse and misuse and access disciplines.

Certain cannabis products are prescribed at present but unregulated illegal herbal cannabis, Dr Gouws said, which is grown incorrectly and bought from the black market will have unknown concentrations of THC’s and cannabinoid concentrations combined with potentially harmful ingredients. Cannabinoid drugs currently used are Dronabinal for loss of appetite during severe illnesses, Nabilone for nausea under similar conditions and Sativex for spasticity.

Conditions of use

If legalised, it will be proposed that objective evidence to support the proposed use of cannabinoids in whatever regulated form must be provided; the manner and duration of treatment provided; a patient must be monitored to ensure efficacy; the treatment outcome reported upon; the physician involved must be a specialist and informed consent by the patient or legal representative obtained.

In questioning the DHA, parliamentarians were particularly concerned that appropriate measures amending the Drugs and Drugs Trafficking Act, the criminal Procedure Act and the Medicines and Related Substances Act were undertaken. One MP remarked that there must be no question of unintended consequences with law enforcement processes in order that criminal procedures under certain circumstances involving cultivation, marketing, administering and research can be clearly separated and easily understood by the South African Police Service.

Dr Joey Gouws said that this matter had already been investigated and the issues involved were with the State Law Advisor at this very moment. It appeared that they were satisfied. The framework for medical use and research had also been submitted, which also included the licensing of growers using controlled cultivation methods for medical, scientific and research purposes. There were various cultivars of cannabis which had different medicinal properties, she said.

Quality controls

The framework being worked to by DHA also includes reaching a standardised, quality assured product for medical use indications, bearing in mind that clinical decision-making in terms of Section 22A(9)(ii) and Section 21 of the Medicines Act must be made to the scheduling of products, Dr Gouws said.

For a while, Dr Joey Gouws said, cannabis as a medicinal drug for pain may remain as a Section 21 drug as things exist until all regulations were in place and registration and classification complete, so that the use could have a controlled start. Herbal classifications may be allowed far earlier.

Feature article……

NHI hoped for over fourteen years….

A White Paper on “The Transformation of the Health System in South Africa” envisaging a functional National Health Scheme or NHI has been published for public comment by Minister of Health, Dr Aaron Motsoaledi. Radical changes to South Africa’s health service to communities are envisaged over a period of fourteen years.

A White Paper usually precedes legislation on the subject in the form of a draft Bill which is mostly published for comment by the Minister whose department has drafted the law. This is before any final legislation is tabled before Parliament for further parliamentary public hearings and debate. Regulations to govern any new structuring of public health would then follow. Therefore, proposals at the moment are at a very early stage and at departmental level and already the Minister has issued a statement on some of the more impractical issues presented in the Paper

The process in this case will undoubtedly be a long and arduous one for the Ministry, since any Bill makes a call for the Minister proposing such a plan or policy at law to make a clear declaration on the financial implications for the state. The massive cost involved could make this one of the major Cabinet decisions since democratic elections were held and recent financial developments must have made National Treasury look at this White Paper somewhat askance.

Big money

The cost to the fiscus would clearly be in the billions, few countries in the world having successfully negotiated the road leading to an option of free national health care for all. The focus, says the SA White Paper, will be initially upon primary health care and mainly in the districts.

To place the White Paper in its context, Nelson Mandela said, on receiving his PhD at Harvard University, “The greatest single challenge facing our globalised world is to combat and eradicate its disparities” but the major question will no doubt occur when National Treasury, in its future appropriations, decides upon which of the greatest disparities it can afford – whether Constitutional imperatives are involved or not.

Objectives

The White Paper, as distinct from any legislation or new framework that might follow, has its objective stated as: “To present to the people of South Africa a set of policy objectives and principles upon which the Unified National Health System of South Africa will be based.”

Various “implementation strategies” are proposed. However, it is acknowledged in the Paper that in the end everything is related back to cost and the White Paper accepts the fact that any plans made are in the light of “the limited resources available”. Yet, nowhere in the world do free national health insurance plans come cheap in part or holistically despite any plans to change South Africa’s health systems structurally even over a period of time.

The plan in this case is to start preventative health care in broad principle and free primary health care for all first but it appears that a fully integrated system has to be agreed initially so that enlarging the system and planning can follow.

Who pays

The taxpayer will foot the Bill, presumably for running costs. Capital costs will assumedly be in the form of raised funds but the White Paper is by no means a financial model, nor it is it intended to be, it seems. Nothing specific is given on financial plans but one has to remember that only 2% of the South African population is estimated to pay more than half of income tax.

The history of providing a national health care system goes back to well prior to 1994 when the ANC, emerging from exile, produced such a paper on the subject or probably better referred to as a manifesto. Free health for all has been a refrain of the ANC for many years.

Earlier White Paper

Dr. Nkosazana Dlamini Zuma, when Minister of Health, also produced a White Paper that seems to have struck a chord that survived. This was before the outbreak of HIV/AIDS, which occurred in the time of her successor, and this Paper stated frankly but logically that “health strategies had to be based on the belief that the task at hand requires the pooling of both our public and private resources”. Sensible talk at the time.

The goal then was “the creation of a unitary, comprehensive, equitable and integrated national health system”, Dr Zuma said. “The challenge facing South Africans was to design a comprehensive programme to redress social and economic injustices, eradicate poverty, reduce waste, increase efficiency and to promote greater control by communities and individuals over all aspects of their lives.”

She gave warning signals to the private sector at the time, particularly those major players in the life assurance industry and the fewer medical aid societies which then existed, that the status quo as it stood could not continue.

It is reported that there have been over twenty White Papers or manifestos on national health for all over the last thirty years.

Getting nowhere

To the immense irritation of many successive Ministries of Health, and particularly to the incumbent Minster, Dr Aaron Motsoaledi, very little of substance has been forthcoming and now, on the subject of national health schemes, a somewhat beleaguered ANC is watching some of the major players opting for overseas development from their profits rather than, in the Minister’s view, by meeting the department of health (DOH) at least half way locally with some of this investment. However, the Paper is somewhat “fuzzy” over the involvement of the private sector.

Bad timing

The launch of the White Paper was an extremely low-key affair considering it followed the shock announcement of Finance Minister Nene’s dismissal. Consequently, Minister Aaron Motsoaledi’s long-awaited presentation went largely without intensive questioning by the media as to its practicality.

To put it another way, since the particular briefing on the White Paper on Health Services Transformation was the first head-on meeting between the media and government minsters following President Zuma’s announcement of the firing of Minister Nene, Minister Jeff Radebe, (ANC -SACP) introduced Dr Motsoaledi to an audience much more interested in questions regarding the shambles in the financial world.

The DOH Director General of Health was not there and a much rattled Minister Motsoaledi presented his plans. No representative of National Treasury was present. The briefing went largely unnoticed by the press therefore.

The central fund

In essence, the White Paper proposes the establishment of a National Health Insurance (NHI) Fund and a policy requiring substantial changes to the way the current health system works by interlocking or possibly by cooperating with both the private and public health care systems. The exact way this will work is not proposed but in principle referred to. Much is stated on departmental restructuring.

There is clear ideology expressed that that health care should be regarded as a social investment and not subjected to market forces. The parallel with Aneurin Bevan, the Welsh coal miner’s son who in 1949, who as the Labour Party left wing socialist Minister of Health spearheaded the establishment of the British National Health Service, is self-evident. Dr Motsoaledi’s plan is to do much the same but this is over fourteen years and in three phases.

The process in the White Paper is described as “unifying the fragmented health services at all levels into a comprehensive and integrated health service”. This implementation process will be undertaken by “six work streams” which are stated as already have been set up, the first being to set up an NHI Fund, the “big pot” that pays for all the services provided. Other teams are to deal with such issues as accreditation of providers and the key to service delivery of an NHI, the beefing up of district health systems.

Health mirrors social success

In passing, it is noted that that the White Paper is careful to integrate its goals with that of the Reconstruction and Development Plan (RDP). The Paper sees itself as the litmus test of developmental issues to redress the past in water, sanitation, electricity connections and health education, all factors leading to better community health.

The Paper enlarges on this parallel with the statement, “With the RDP’s focus on meeting basic needs, the development and improvement of housing and services like water and sanitation, the environment, nutrition and health care represents its most direct attack on ill health.”

“It follows that trends in health status during and following the implementation of the RDP will be amongst the most important indicators of the success of the entire programme. The Department of Health aims to ensure that the health sector succeeds in fulfilling this vital role in ensuring progress.” Obviously an attempt to get higher up in the queue for funds.

The three tiers

The White Paper emphasises that the “health sector must play its part in promoting equity by developing a single, unified health system” and also stresses that “the three spheres of government, NGOs and the private sector will unite in the promotion of common goals.” Hence, the first phase is very much focused upon the delivery of free primary health care at district level and at “at first point of contact” by the patient.

There are some twenty-four chapters for the technically minded and medical professionals to pour over but in theory the country will be divided into “geographically coherent, functional health districts. In each health district, a team will be responsible for the planning and management of all local health services for a defined population in each.”

In passing the Paper notes that peri-urban, farming and rural areas will fall within the same health district as the towns with which they have the closest economic and social links. “The fragmentation and inequity created by the past practice of separating peri-urban and rural health services from the adjacent municipal health services must be eradicated”, the Paper says.

National pay parity

The Paper lays down that “There will be parity in salaries and conditions of service for all public sector health personnel throughout the country”, adding also “which will include appropriate incentives to encourage people to work in under serviced areas.

The whole idea would seem to involve many billions of rands per year from the taxpayer, the taxpayer presumably having options to re-structure their own insurance cover bearing in mind the eventual “free” system. This is aside from a massive CAPEX call to build the system. The details of either are not indicated, this stage not having been reached assumedly where any further infrastructure build is being considered, so commentators have found it difficult to draw conclusions without knowing the financial burden other than its enormity in the long-term.

As its so happens, South Africa’s current private hospital system is rated the fourth best in the world but the moral point is made again and again in the White Paper that the current system is only for those who can afford good medical intervention. Options on how the private sector will be accommodated are not debated in any detail.

U-Turn

However, in a recent media interview, Dr Motsoaledi backtracked on the inference that all had to use the NHI and that only small sections would be left open for medical aid schemes to negotiate with the public.

The impracticality and overwhelming costs of this must have got home to the Minister, probably in debate with stakeholders, and the general direction seems to be to leave the choices as they are. Rather the impetus will be to focus the White Paper conclusions towards the re-building of primary health care systems and the establishment of improved health care in the more underdeveloped provincial zones and under-serviced particularly rural areas.

The big factor

On the private medical profession itself, the Paper says, “Private health practitioners should be integrated with the public sector with regard to the provision and management of services”. Policies adopted “should apply to all private practitioners including private midwives, general medical and dental practitioners, specialist obstetricians and gynaecologists, paediatricians and private pharmacists.

Services delivered by occupational health practitioners, and prison and military health authorities, should be subject to the same principles.” Once again, Dr Motsoaledi has toned this down somewhat in subsequent statements but some sort of pooling of resources is envisaged.

Accreditation according to DOH “rules”

The White Paper stresses that all institutions and health practitioners will have to be accredited to an Office of Health Standards Compliance (OHSC) “based on set criteria” and therefore it follows that only those that are accredited by the OHSC as providers, whether suppliers or medical practitioners, will get payment from the NHI Fund, the Paper says.

The White Paper admits that because of potential problems envisaged with a too rapid introduction of OHSC accredited private provider systems, public facilities will remain the dominant public health care providers funded by the government for the first few years. Accredited private providers will be introduced gradually, particularly in currently under-serviced areas, the Paper continues.

Where full and/or part-time OHSC practitioners are in short supply, DOH say that private practitioners’ services will be used through referral contracts, and patients will be referred to a general practitioner by the public health system it seems.

Health for all

The White Paper as published sees the end game as an NHI Fund being “financed” by compulsory means from all citizens and permanent residents and the fund will purchase a range of health services from accredited public and private health institutions, as well as contracted private health practitioners.

The end-scenario in the White Paper as published is that all citizens and permanent residents will be able to access the NHI Fund for health services without further payment. Dr Motsoaledi has clearly recognised that such a journey for his Ministry is going to be a long one.

Whilst, again this rather unclear document sees medical schemes as only being allowed to offer “complementary services” not provided by the NHI system this is where the Minister has backtracked even further.

Even specialists handled by NHI

Access to specialists will be dealt with by the NHI system according to diagnosis and needs, says the Paper. Whether DOH has the competency, skills and follow through, even if over fourteen years, and whether doctors, GPs and medical professionals “buy in” to the idea will no doubt be the subject of much media comment before the matter gets to Parliament.

Opposition members have already discounted the programme as “reckless”, probably voicing the opinion of many of those who prefer the current system with their medical aid schemes and the reliability of service they get as a result.

Bodies such as the Free Market Foundation have stated that the State would be better occupied worrying about health services for the poor and not overextending State finances on grandiose schemes. Even the trade unions seem unhappy, who have spent many years to achieve medical aid cover as part of their pay packages, it is reported.

Big plans, big obstacles

No doubt matters regarding the White Paper will emerge in the business programme of the Portfolio Committee on Health, once Parliament re-opens – perhaps with a workshop. In all, the White Paper outlines some undeniable health system needs in South African but at the same time the Paper seems very low on the issues of practical application. Probably also the Minister will have to make a lot more adjustments as National Treasury hopefully dig South Africa out of its financial constraints, at long last recognised.

Must precede world health HIV/AIDS conference….

Dr Precious Matsoso, Director General, Department of Health (DoH), has told Parliament that it is essential to have the South African Health Products Regulatory Authority (SAHPRA) in place before South Africa hosts the World AIDS Conference.

On the health agenda also in South Africa, she added, is a World Hospitals Conference and Regulatory Agencies Conference, in which case the existence of a working SAHPRA was almost obligatory. Dr Matsoso was in Parliament to brief MPs on the DoH fourth quarter results.

Dr Matsoso has recently been elected as an Executive Board Member of the World Health Organisation (WHO) and, in addressing the portfolio committee on health, all MPs congratulated her They expressed value of her appointment to South Africa in the context of promoting health on the sub-continent.

Minister absent

Dr Aaron Motsoaledi, the Minister of Health, was away an overseas visit for what is undoubtedly DoH’s most important presentation of the year, the last quarter, and both departmental officials presenting and responses from parliamentarians were relatively upbeat on improvements in DoH performance results.

In reporting on the final quarter as far as performance and finance was concerned, Dr Matsoso advised that in the year under review, aggregate pre-audited spending so far was at 98.4% of the total budget of R30.8bn, i.e. R30.3 bn. The R489m not spent in the year was for a number of reasons but mainly because of staffing vacancies provided for but not filled.

In general, she said there had been “an overall improvement in spending and compliance, and tightened monitoring and evaluation both at national and provincial level.”

New drive for medical staff

Attracting qualified staff to serve in government health was still a major problem but she stated that DoH intended to publish magazines and undertake promotions that were to be part of a new image intended to represent the changes that were taking place in public health.

Major items covered in the DoH presentation included the overall integration of health services on a national basis; progress with the ten National Health Insurance (NHI) pilot programmes; the situation with regards to HIV/AIDS; improved access to community-based primary health care facilities; and progress with legislation, particularly the Medicines and Related Substances Amendment Bill.

Getting to grips with HIV virus

HIV and AIDS, TB and maternal child and women’s health was a separate programme and DoH had recorded over 9.5 million HIV tests in the year under review. The year ended with a total of 3,103, 902 clients now registered on anti-retroviral treatment (ARVs).

In discussion with concerned MPs, it emerged the number of HIV positive cases was increasing. The department acknowledged that was always going to be the case until changes occurred in people’s habits, the largest problem sector in the fight against HIV/AIDS. The highest incidence of HIV was amongst women between the ages of 15 and 24.

Clearly, the country was on top of AIDS as a disease with the use of ARVs but the unknown and major worry was incidence of unaware persons not knowing or not caring on how to avoid becoming victims of the HIV virus. This was due to a variety of reasons, Dr Matsoso said, and she told members that “DoH had started a project aimed at showing young women how to take charge of their lives; how to negotiate with older men; and how to take decisions.”

TB prevalent but under control

On TB, the most worrying issue was the much publicised multi-drug resistant virus. Over 120 professional nurses in service had been trained to initiate MDR TB treatment. Matters were now under control. In general terms on TB treatments, fifty hospitals had been assessed on TB criteria and diagnosis.

In passing, Dr Matsoso added that 90% of correctional services centres were now conducting routine TB screening. TB was still mainly associated, she said, with impairment of the immune system as a result of being HIV positive or for nutritional reasons, both issues being usually coupled together when dealing with those below the breadline.

Community stress factors

In the area of primary care, various DoH heads of departments reported and it became apparent that 169,418 people had been counselled and screened for high blood pressure, a major problem in high stress and impoverished communities.

A start had been made on mental disorders by commencing a registry system and a mobile SMS application was being piloted in the three districts to improve reporting times for ARV treatments to chase up on irregular calls for treatment.

One system, also at pilot level, was called “MotherCall” and dealt with mother care and maternity issues on an SMS basis, especially where calls to clinics by patients were needed on a regular basis but this was found to be somewhat restrained by cell phone coverage in the deeper rural areas.

Almost malaria free

Only one malaria endemic district had reported any malaria cases, which had been dealt with within 24 hours of diagnosis. In all areas, 837 645 high risk individuals had been vaccinated against influenza. A draft model for rehabilitation and disability services had been developed and was ready for discussion with stakeholders and presentation to the National Health Council.

There had been 985 cataract surgery operations for the poor without medical aid cover but this area was a growing problem and the cost of spectacles added to eyesight impairment issues, affecting mainly the poor as far as education was concerned.

Mum on NHI

Dr Matsoso seemed somewhat reluctant to talk on the monitoring and evaluation that had taken place in ten NHI pilot districts, probably because DOH had not finalised its White Paper on the subject and conducted its talks with National Treasury. She conceded, however, that recruitment of various categories of health practitioners needed for the NHI pilots had been below expectations.

A departmental spokesperson confirmed that a dispensing and distributing system for centralised chronic medicine had been implemented for three-quarters of the facilities in all ten NHI districts. A system was also being tested whereby monies paid by patients was retained by the unit involved in a self sustaining exercise and not remitted to National Treasury.

He said that in the past three years of the particular pilot, R1.3bn had been collected by 13 hospitals, R450.6m being collected and held for the year under review.

Infrastructure build

In general, 700 primary health care facilities were under construction or being opened in the ten NHI districts and some 3,500 computers on LAN equipment had been distributed and installed amongst the pilot areas enabling systems to work in individual clinics and hospitals with networking within their particular environment.

Further on primary care and in order to reduce the maternal mortality rate, a 53.9% rate of ante-natal first visits before 20 weeks of pregnancy had been achieved, against a target of 65%. The actual maternal mortality rate had been 132.5 per 100 000 live births. This was very much a question of education programmes.

Nursing practices and qualifications

On nursing generally, a further departmental spokesperson on the issue confirmed that four regional nursing training centres, or pilot “colleges”, had been established and were functional in Mpumalanga, Limpopo, Gauteng and North West. However, no public nursing colleges had yet been accredited in terms of the new system announced since the whole question of accreditation was still being debated with both stakeholders and nursing bodies. Most of this debate involves whether nurses in training should get or not het “field training” after each level of training.

A Chief Nursing Officer had now taken on her duties in a new DoH post who had the critical job of dealing with the major investment and finance required to “train the trainers” bearing in mind all colleges must fall into the Higher Education specifications now required. The entire matter was going forward, however, she said.

NHI still in principle is alive and well

On legislation, Dr Matsoso reported that the draft white paper on the forthcoming NHI Bill was ready to go to Cabinet; the Medicines and Related Substances Amendment Bill had been tabled and was going through the parliamentary process with public hearings completed; and amendments to the Traditional Health Practitioners Act had been proposed.

A regulatory impact assessment was being conducted on the draft Control of Marketing Alcohol Beverages Bill.

MPs raised the question of schools feeding which they stated was not ideal from a nutritional aspect. Dr Matsoso agreed and said it was important to change the school feeding programme, as children should not be served just soup and bread. There was a need to look at whether the nutrition provided at ECDs, crèches and pre-schools was appropriate generally. She said she was aware of the problem and it was to be addressed.

The larger picture of health in SA

Also, at schools generally, she said, over 200,000 learners had been screened with resultant indications that as many as 54,000 schoolchildren with some sort of health problem or impairment existed that could affect basic education. These students could suffer in their approach to matriculation and subsequent job attainment. Nutritional problems and troubled backgrounds were at the forefront.

Drug “stockouts” still there

Dr Anban Pillay of DoH addressed the issue of “stock outs” and drug shortages and said that, on the whole, DoH facilities were unfortunately geared nationally just to treat patients, rather than explaining to them how the treatment programme worked. This was being addressed.

Dr Pillay said stock outs could be supplier problem, as well. There had been a time when suppliers were unable to supply as many as 168 items and there were was a contractual agreement in place usually requesting suppliers to advise immediately when they anticipated problems. In this case, the 168 items that suppliers were unable to supply were not available either in the private or public sectors.

Online with the world

He said that DoH had approached the WHO for a list of pre-qualified suppliers outside South Africa that could be considered and some stocks like Benzylpenicillin and Atropine had had to be flown in from other places. Dr Matsoso commented that in some cases the U.S., Canada, Australia, Europe and the U.K. could indicate that there was a general stock out problem worldwide.

In most cases, however, Dr Pillay said that stock outs were as a result of a local facility forgetting to order and would run out between orders but barcode systems and central stock controls had been upgraded and the whole question of stock outs was improving, he said.

A system on stock control using cell phone technology was expected to take over the manual system completely but currently, 600 clinics were linked to the SMS system and more would be linked. A call-free line for patients had been established for any patient to advise if they could not get drugs from a particular clinic. Over 20 000 items were stored in an emergency “buffer stock” in Centurion, Pretoria.

Other stock outs could occur when pharmaceutical manufacturing companies closed for factory maintenance at the same time resulting in shortages and DoH representatives said that this could be solved by common negation on maintenance certificate timings.

Ebola never an SA issue

Finally, Dr Matsoso commented on the outbreak on the continent of Ebola.

DOH, she said, had provided humanitarian financial assistance for the recruitment of Cuban doctors to provide health services in Sierra Leone and had established a knowledge and information sharing platform on various areas of collaboration with Botswana, Uganda, Namibia and Ghana.

In local terms, DoH Primary Health Care Services had seen over-expenditure due to the appointment of 25 local environmental health practitioners in response to the Ebola outbreak as a precautionary measure.

DOH responds on new Medicines Bill……

Dr Anban Pillay, DDG of the department of health (DoH), has made it quite clear in answering public comments on the proposed amendments to the Medicines and Related Substances Act that their concerns regarding foodstuffs are not just confined to the labelling of food and providing a list of the contents of any food products but also the actual food content itself contained in the product and any harmful effect it might have on the consumer.

In this regard, Dr Pillay has said there was to be much closer contact between DoH and the department of Agriculture, Forestry and Fisheries (DAFF), the lack of co-ordination becoming apparent during the recent scandal when horse meat and donkey meat had been discovered in the contents of named foodstuffs brands without any public awareness to this effect.

This and many other comments were made on submissions recently put before the parliamentary portfolio committee on health during the debate on the Medicines and Related Substances Amendment Bill.

No separation from cosmetics

Dr Pillay also made it quite clear that comments in submissions suggesting that food stuffs and cosmetics be isolated into separate legislation parallel with medicines and related substances was a non-starter. DoH, he said, had already recruited 25 new permanent staff members that would be working for the South African Heath Products Authority (SAHPRA) who were in the process of considering a food agency, food being very much within the ambit of the one Act.

A good number of the changes in the Bill before Parliament arose in the area of vitro diagnostics (IVD), or tests with equipment which assisted medical diagnosis by sampling body tissue and fluids. In this regard, the wording of international medical regulatory bodies had been used whereby such equipment had to meet certain performance requirements. This was in contrast to medicines and related substances issues which dealt primarily with matters of efficacy.

Big retailers excluded

On the question of the issue of licences to trade issued by the new Medical Control Council (MCC), it had been conceded that retailers dealing exclusively with bulk products classified as unscheduled medicines did not have to comply with all SA Pharmacy Association requirements or obtain a licence from the MCC.

Comments in submissions had been made and by the opposition that the regulating body would find it difficult to exercise its authority with regard to product advertising in all forms of electronic media, particularly if it extended to social media. Dr Pillay said that this was acknowledged but he asked for his detractors to note that advertising and marketing world was an ever-evolving subject and attempts had to be made to deal with false claims and failure to meet requirements in all forms of advertising media whatever the problems of doing so.

Debate on medical devices

Regarding criticism on the descriptions and definitions in the amending Bill with regard in the approval of medical devices and the ambits of inclusion and exclusion, Dr Pillay said DoH had fallen back on an updated version agreed upon by the International Medical Device Regulatory Forum, which was more appropriate, he said.

Considerable debate took place upon the issue of controls on pricing, raised in a number of written submissions. DoH had agreed that the amendments would clearly state that the agreed pricing committee would be the final body to make recommendations on such matters to the minister of health. Meanwhile, the MCC would confine its activities to quality, safety and efficacy, not pricing.

Furthermore, Dr Pillay confirmed it was the pricing committee alone who were to “pronounce on marketing, bonusing and pricing matters”, bonusing usually being related the incentives to doctors to recommend certain medicines in relation to price.

Traditional medicines

As expected, the EFF and the ANC raised the question of traditional medicines and asked why there was no reference to such in the “description of medicines and products”. On this, Ms Malebona Matsoso, DG of DoH, replied that department was fully aware of the need to incorporate traditional medicines.

She said that DoH was now distributing a booklet on the process they intended to use to regulate for traditional medicines and how DoH planned to carry out any regulations. The booklet was not available at the time but would be sent to parliamentarians, she said.

The DG, DoH, said that eventually SAHPRA would regulate all products that were processed in laboratories as well as the plants that were used during the process of making medicines. She explained that one of the main drivers for the establishment of SAHPRA was that MCC appointed members were contributors from different industries and not only public servants.

The establishment of SAHPRA therefore would be on a permanent DoH staff member basis and would deal with this as well as foodstuffs and cosmetics in terms of “products” under the Bill. Ms Matsoso confirmed again that traditional medicines and products had not been excluded under the Bill since the Bill included all products. How the regulations were to be extended to include traditional medicines was now being established, she said, and university research particularly from the University of the Western Cape and UN World findings would be used.

Animal world

Despite some objections in written submissions, DoH was insistent that veterinarians had to ensure that they were issued with licences wherever medicines were either compounded or dispensed. Also, Dr Pillay pointed out that the new Bill would not regulate for electronic-medical and radiation devices, the worry of one submission, and hence the question of the Hazardous Substances Act did not arise, he said.

In an earlier meeting with the DoH, also led by Dr Anban Pillay, the portfolio committee debated the section of the Medicines and Related Substances Amendment Bill that covered the formation and running of SAHPRA. What SAHPRA would do and the manner it would operate in the industry, he said, would be dealt with by the regulatory process to be devised.

Other articles in this category or as backgroundhttp://parlyreportsa.co.za/health/medical-food-intellectual-property-tackled/ http://parlyreportsa.co.za/health/sa-allow-avoidance-medical-patents/
http://parlyreportsa.co.za/health/medicines-and-related-substances-bill-now-tabled/

Evidence on cannabis needed…

For the moment at least, the possibility of the legal medical use of cannabis by injection or oral dose, the medical manner in which drugs are used to reduce pain and suffering, is out of the question. This was decided at parliamentary portfolio committee level recently, the matter not going for vote or recommended for passage to the National Assembly.

Nevertheless this does not mean, in the long term, that the matter has been totally rejected by Parliament. IFP member, Dr. Narend Singh, in the last meeting of the portfolio committee on health before the recent short recess, introduced a Private Members Bill known as the Medical Innovation Bill.

Despite the Bill at this stage having been rejected at this stage by the committee, many tributes were paid to the late Dr. Mario Oriani-Ambrosini, IFP, who had tabled the idea in the last Parliament and formulated the original wording.

Basics first

Parliament, after debate at committee level, has suggested that more international opinion on the subject is garnered and the results of any further medical research is considered before parliamentarians are asked to consider laws on the subject. They concluded that regulations, following such a law, would be difficult to enforce; that more work had to be done on broad legal considerations and that decisions, which would be difficult, must not be based upon emotion but empirical evidence.

Considerably more public and professional opinion locally had to be sought as well, they said, but the door was not closed on the issue. Most MPs referred to the possible unintended consequences of such a law where the legal use of such powerful drugs entering into the crime world and general abuse by habitual drug users was a distinct possibility.

Implementation of a change in government health policy towards cannabis, commonly referred to as marijuana, is allowed by the proposed Bill with a change at law to the approach in the treatment of cancer and other incurable diseases suggested.

Best practice guides

Existing treatments alongside such “innovative complementary therapies” were recommended to be administered only at “nominated medical treatment research centres”. The Bill, amongst its objectives, proposed to “codify existing best-practices to allow decisions by medical practitioners to innovate in cases where evidence-based treatment or management is not optimal or appropriate or because the available evidence is insufficient or uncertain.”

The Bill also seeks to “deter reckless, illogical and unreasonable departure from standard practice and legalise and regulate the use of cannabinoids for medical purposes and for beneficial commercial and industrial uses.”

Underworld the enemy

The DA opposition stance on the issue was that despite the possible treatment properties for cancer, any such drug when ingested as a food into the stomach could lead to severe addiction and therefore much criminal abuse if such a manner of formulation became accessible via the underworld to the wider public.

Dr W James (DA) said the Bill was really about innovative approaches to cure and treat and consequently any parliamentary debate had to be about medical innovation as such. Referring obviously to cancer he said, “in terms of molecular cell biology, a cure had to prevent the problem from re-occurring. Unfortunately, science in terms of finding a cure as such had not advanced in the case of cancer.” Therefore treatment, he said, was a completely different subject for consideration, especially in the case of cancer.

Consensus across party lines indicated that whilst the proposals would legitimise the intended purpose of alleviating the pain and suffering of patients, with such a change would also come the import or local manufacture of cannabis for medical purposes in terms of commerce, with a consequent difficult accompanying regulatory process.

Input needed

Bearing in mind the unintended consequences of such a proposal, MPs generally felt there had to be a lot more professional opinion on the subject. Parliament was not the forum for such a debate, at least not without more input from science-based research and advice on the subject of how to regulate, it was decided.

Finally, it was felt that the medical profession should be the final arbiters on scientific exactitudes and whether such an innovation should be adopted and how. Only then should the proposals be considered by Parliament. One ANC member remarked that “as South Africa was a highly opinionated nation such a matter should be opened up much more for more public consultation and advice.”

Dr. Narend Singh, when asked if he was dissapointed that the Bill had been rejected at this stage, replied that the tabling of the Bill had been part of a process. “The matter is now on the backburner”, he said, “I am very happy that this should be the case. I would have be most surprised if matters had gone further at this stage. We will hear more though in due course, now that we have laid a foundation”.

MCC to go….

The parliamentary portfolio committee on health recently called for written comments on the recently tabled Medicines and Related Substances Amendment Bill which proposes to replace the existing Medicines Control Council with a new entity called the South African Health Products Regulatory Agency (SAHPRA).

The new entity with a new body that will reflect better, the proposals suggest, the many facets and changes that have occurred in the industry.

The Bill also seeks to amend existing legislation to replace the word “products” with the word “medicines” and defines the expression “scheduled substances” in order to more correctly reflect what the anchor Act is in his view trying to achieve, the background to the Bill states.

Complementaries now included

It is also proposed that the minister of health and therefore the department (DoH) will have a far wider scope of regulatory control and the Bill also adds the expression ‘complementary medicines’ to its definitions.

The Bill has the intention, DoH says, of speeding up registration of medicines and will allow ‘mutual agreements’ with other worldwide drug registration institutions to enable the process of acceptance or rejection to take place. It is in this area that opinion from stakeholders is expected to be submitted.

A new body of committees made up of experts and specialists will assist DoH with such a process, the Bill says, but the decision making processes on the subject of registration of new drugs appears to be remaining a private matter within the department.

Other articles in this category or as backgroundhttp://parlyreportsa.co.za//health/medicines-related-substances-bill-tabled/ http://parlyreportsa.co.za//health/nhi-focus-better-nursing-says-doh/ http://parlyreportsa.co.za//health/sa-allow-avoidance-medical-patents/

Pilot NHI facilities to get IT systems

An impassioned plea in Parliament by minister of health, Aaron Motsoaledi, when presenting the strategy and annual performance plan of the department health (DoH), that nursing in South Africa should return to “the old days” was received well across party lines during a meeting of the portfolio committee on health.

He said he did not like the current system whereby nurses were trained at university, gaining all their four coloured bars in one learning process before gaining practical experience in the various disciplines. What is going to happen he said, is to encourage a heightened understanding of patient care with more bedside experience during training, This led to a round of vocal support from all parliamentarians in the newly elected committee.

Practical qualifications

Dr Motsoaledi said that many nurses with four bars on their shoulder-tabs often had less practical nursing experience than some who only had one bar, meaning that less experience in the real basics of proper nursing care was becoming prevalent.

Change was now being instituted whereby each specialist phase in knowledge attainment would be coupled with a period of field training experience to gain a bar in order to return nursing to proper holistic care principles. Nursing training was to be returned to a seven year period to incorporate periods of field experience, rather than the current crash course system of four years.

He said to MPs that it was “very difficult to send a new highly qualified nurse on bedpan duties for her first duty.” He received a strong endorsement of the new approach from a cross spectrum of all members. He told parliamentarians that five public nursing colleges would be accredited to offer nursing qualifications under a new system in 2014/5.

NHI will meet world standards

Dr Motsoaledi detailed all eight strategic goals of DoH and referred immediately to the national health scheme, the implementation of which he said was not “if” but “when”. South Africa’s NHI would meet international standards and use internationally accepted regulations, he said, but he did not answer directly a member’s question on a date when the pilot would end.

However, he expanded on the fact that the current NHI project, a project which involves 700 public health facilities, would be the subject of new patient registration systems with IT backup and electronic health care data collection. The revised administration systems would reduce patient waiting time, he said, and in addition a mobile phone data collection and communication system was to be introduced.

He also said it was the intention of DoH to have a functional national pricing commission in place by 2017 in order to regulate health care in the private sector. DoH would again revise methodology and also legislate for the determination of pharmaceutical dispensing fees.

Dr Motsoaledi told the committee that an Institute of Regulatory Sciences was to be introduced and regulations for the function of an Office of Health Standards Compliance to prescribe norms and standards brought into being.

He was adamant that nearly 4,000 primary health care facilities with functional committees and district hospital boards would be in place by 2018/9 and said that 75% of all primary health care clinics in the 52 health districts would qualify for the international terminology of “ideal” by the same date.

Standards

This involved a clinic or facility passing a test based on a regimen of some 180 standards, from infection control to waiting room facilities. He was candid enough to say that a major issue was now to control a leaning by both municipalities and local government to build new infrastructure to meet patient demand and NDP targets, rather than maintain and improve existing services which had exactly the same result.

He also wanted to see standards developed countrywide on building costs per square metre since, he complained, a building going up in one province can vary by 100% from another province. He said DoH had little power to influence the activities of health MECs and wanted to see a list created of “non negotiable items” so that some DoH control could be exercised over municipal budgets and spend.

Overview

His discussion with parliamentarians and his briefing for new MPs roamed over a wide range of health subjects, from female contraception and cancer screening to child health and on the issue of HIV/AIDS, he focused on the need to encourage breast feeding at the expense of formula feeding. He complained that breast feeding was as low as 8% nationally and wanted to see more, even amongst HIV positive mothers. He gave outcome figures to support his view.

Dr Motsoaledi spent some time detailing the moves by DoH to introduce more emphasis on preventative health care and education by going to the root of the problem rather than chasing curative health targets, stating that education towards better diets had to become a part of an SA way of life.

He said that for each person who died in South Africa, eight were in hospital and that preventive health care education starting nationally at school age was the only way in his view to reduce poor health in a substantial manner. A post of an advisor to the deputy minister of health was to be established on this subject and a White Paper on affordable heath care produced.

HIV/AIDS

On the subject of HIV/AIDS, he repeated the statement which he said he had made on a number of occasions to the effect that children born to HIV positive mothers should, by law, be tested for mother-to-child transfer of the disease. This should happen if child mortality in South Africa was to be tackled successfully, he added. He did not discuss the constitutional issues involved.

He said the total number of people remaining on ARVs was targeted by DoH at 5.1m for the end of 2018/9, the current figure for 2014/5 being 3m. He added that some 2.4m were currently on the regimen. DoH targets for HIV tests among the population aged between 15-19 years are targeted at 10m annually, he advised.

TB

On TB control programmes, Dr Motsoaledi said a 79% treatment would be reached for 2014/5 and this was to be targeted at 85% by 2018/9. The TB defaulter rate was 6% presently and this was to be reduced to 5% over the same period. He advised that there were over 400,000 TB cases recorded in correctional service facilities and a focus was now to give inmates the correct kind of increased TB and HIV diagnosis and better treatment services.

He emphasised that DoH had to ensure regular TB prevention, screening and treatment carried out by mines by enforcement of compliance regulations for approximately 600,000 miners and employees of associated industries. He said that DoH was to “heighten” diagnosis and treatment of TB in peri-mining communities “in six districts with a high concentration of mines using DoH TB and HIV mobile units”.

Dr Motsoaledi continued that life expectancy of South Africans had to be raised by 2030 to 70 years, at present being dragged down by HIV/AIDS and TB into the ‘fifties, after having reached 60% at one point recently.

In general, however, there were more people living as well as more people living longer. The cure rate in Western Cape and Gauteng had now reached 81% but it was slower in other areas, averaging at 74% for the country. The national target was an 85% cure rate.

Preventable health care

However, on non-communicable diseases, Dr Motsoaledi said that the rise in hypertension numbers was “explosive” and high blood pressure problems were therefore very much part of the preventative health care plan. 5m people were targeted for counsel and screening for high blood pressure in the next four years and a further 5m for raised glucose levels.

Obesity was also a major problem and this was targeted to be reduced by 55% for women and 21% for men in the next four years. This was currently being started with school programmes. There was also a DoH programme in place reduce injury through, accidents and violence by 50% from the high levels of 2010.

Other articles in this category or as backgroundhttp://parlyreportsa.co.za//health/health-dept-winning-on-hiv-aids-therapy-and-tb/http://parlyreportsa.co.za//uncategorized/competition-commission-promises-health-care-inquiry/http://parlyreportsa.co.za//uncategorized/state-acknowledges-responsibility-to-increase-health-staff/

Once again, a tax on sweet drinks and beverages arises….

Professor Melvyn Freeman, head of non-communicable diseases, department of health (DoH), says the department is re-looking at the issue of introducing a sugar tax to encourage South Africans to consume less sugar.

His comment comes as a result of the publication of the World Health Organisation’s Global Cancer Report 2014, which reports that tobacco, alcohol and sweet drinks are driving a rapid growth in preventable cancers.

More than 30% of cancer deaths could be prevented by modifying or avoiding key risk factors, says the fact sheet, and these include tobacco use; being overweight or obese; unhealthy diet with low fruit and vegetable intake; lack of physical activity; alcohol use; sexually transmitted HIV-infection; urban air pollution and indoor smoke from household use of solid fuels.

Poor countries worst hit

More than 60% of world’s total new annual cases occur in Africa, Asia and Central and South America. These regions account for 70% of the world’s cancer deaths. It is expected that annual cancer cases, WHO says, will rise from 14 million in 2012 to 22 within the next two decades. Obesity, particularly with schoolchildren, is considered a problem by DoH locally, according to an earlier report to Parliament by minister of health, Dr Aaron Motsoaledi.

Analysts say, while it is important for governments to encourage people to take responsibility for their own health and make changes to their diet and lifestyle, regulators should consider controlling alcohol and sugar consumption in the same way as tobacco products.

“There is no final decision on a sugar tax as yet, but it is an option that is being considered and we are assessing all relevant factors around this,” says Prof. Freeman. The R12bn South African sugar industry is cost-competitive, consistently ranking in the top 15 out of approximately 120 sugar producing countries worldwide.

Also the sugar industry provides employment in job starved regions often in deep rural areas where there is little other economic activity or employment opportunity. Opportunities for this industry lie ahead and include biomass for renewable energy. In addition, the SA sugar industry has transferred 21% of freehold land under cane from white to black owners since 1994 off a base of 5%.

Sweet story

The South African sugar industry generates an annual estimated average direct income of over R12 billion. Sugar is manufactured by six milling companies with 14 sugar mills operating in the cane-growing regions. The industry produces an average of 2,2 million tons of sugar per season. About 75% of this sugar on average is marketed in the Southern African Customs Union (SACU). The remainder is exported to markets in Africa, Asia and the USA.

University of the Witwatersrand School of Public Health director Karen Hofman said it was not clear if a tax on beverages would be feasible, but even if it were, it should not be seen as a silver bullet. “Any regulatory effort will only ever be part of the solution. People should be free to eat and drink what they like, but they need to have a full understanding of what they are consuming,” says Hofman.

She adds that she is unaware of a specific tax on sugar anywhere in the world. “We do know that taxes have been successfully introduced in several countries, including France and Mexico,” says Hofman. Such taxes have been introduced on those who use sugar in some form of manufacturing or food and beverage supplies.

Obesity and SSBs

In the USA, the term sugar-sweetened beverages, or SSBs, is used – which are drinks sweetened with sugar, high-fructose corn syrup, or other caloric sweeteners. They are a significant source of nutrition-less or “empty” calories in the American diet, say some, and a significant contributor to the current obesity epidemic there. In the USA, researchers say that if the taxes are large enough they could reduce consumption and the revenue from these taxes to be used on obesity prevention.

Here in South Africa, Discovery health representatives has publicly cautioned against placing too much emphasis on the link between sugar consumption and preventable cancers. Their Derek Yach says, “Tobacco remains by far the most powerful single determinant of cancer, accounting for 90% of the lung cancer cases and about a third of all cancer deaths.” He calls for all resources to focus on this area.

In a country like South Africa, with limited financial resources, he says, “a focus on taxes on sugar to reduce cancer is a misplaced policy which will have little impact on cancer incidences and distract people from the major diet issues – which are to increase healthy food intake.”Previous articles in this category or as backgroundhttp://parlyreportsa.co.za//cabinetpresidential/sa-health-welfare-starts-in-small-way/

NHI threatened by lack of doctors, professionals….

Lack of doctors and nurses in public health institutions still bedevils South African the public health system and could stymie plans to instigate a national health insurance programme as part of the plan to re-engineer the primary health system and to introduce quality health systems.

This was said by Dr Aaron Motsoaledi when updating members of the portfolio committee on health on the state of progress with National Health Insurance (NHI) pilot projects, these being eleven selected health areas which included both full hospitals and clinics in the Eastern Cape, Free State, Limpopo and Mpumalanga.

Health building programme going well

After dwelling on the successes of the department of health enumerated by President Zuma in his State of the Nation Address, including the 300 new health facilities built over the last five years, including 160 new clinics and the fact that 2.4million people were initiated on antiretrovirals, Dr Motsoaledi turned to what he referred as “the major problem facing health in South Africa”, the inability to retain the services of doctors and nurses.

He said that sub-Sahara Africa was now nominated by the World Health Organization as a crisis area simply because this is where the paucity of doctors and nurses was being felt most. He said the inability to pay the right kind of money to attract highly retained staff was a common problem to many countries.

He quoted Canada which he, had recently visited who were losing staff, he said, in great numbers to the USA but said they were lucky inasmuch as professionals from Africa were filling those gaps. Dr Motsoaledi said that the problem of lack of doctors had to resolved before the NHI was rolled out, South Africa having one of the lowest patient to doctor ratios worldwide.

“No steal” agreements

He said that Middle East countries and the USA had to agree not to include on their recruitment agendas professional medical staff from countries such as South Africa where health was in a developmental stage and such fragile staffing ratios existed.

Dr Motsoaledi spent considerable time updating members of parliament on the process of grading hospitals and clinics, where maintenance of facilities was a critical issue. “If a facility is maintained properly within a cyclical programme of repairs and replacements, then we shall be able to expand our services but if not, we shall go downhill on this issue”

He quoted statistics which showed a cost R2 for each rand of original cost of repairs if maintenance were performed on schedule each year as against R60 rand per rand of original cost if nothing was done to a particular facility for ten years. He showed breakdowns of the hospitals and clinics in the NHI test area where in many areas, either electrical, plumbing or inability to generate hot water was leading a facility to be condemned.

He said the infrastructure build and repair and maintenance programme were part of a SIP programme generated by the current presidential priority build programme to correct this and he was confident that breakthroughs would be made. Innovative ways, he said, were being found to solve problems such as new types of lesser cost buildings and by contracting GPs to work in public clinics.

Idea is to speed up registration of medicines….

A new Bill has been tabled in Parliament, the Medicines and Related Substances Amendment Bill which proposes to replace the existing Medicines Control Council with a new body that will reflect better, it says, the many changes that have occurred in the industry.

It is proposed that the minister of health and therefore the department (DoH) will have a far wider scope of regulatory control and adds the expression ‘complimentary medicines’ to its definitions. The Bill has the intention, DoH says of speeding up registration of medicines and will allow ‘mutual agreements’ with other worldwide drug registration institutions to enable the process of acceptance or rejection take place.

Committee experts

A new body of committees made up of experts and specialists will assist DoH with such process, the Bill says, but the decision making processes of the committee on the subject of registration of new drugs will still be kept private as is the case in the principal Act since the proposals are silent on this issue.

The new body will be called the South African Health Products Regulatory Agency (SAHPRA) and according to the proposals will have a far wider regulatory mandate on activities across a broader spectrum of medical products. It will extend the base of control and its services to cover foodstuffs, cosmetics and the newly embraced complimentary medicines.

Business Day reported that experts from the US were assisting in the setting up of SAHPRA but gave no details of where these experts emanated from.Previous articles in this categoryhttp://parlyreportsa.co.za//health/pharmacies-labour-relations-changes/ http://parlyreportsa.co.za//health/sa-allow-avoidance-medical-patents/

More controls for pharmacies to consider…..

An amended set of rules for pharmacies relating to good pharmacy practice were published for public comment by the South African Pharmacy Council, mainly related to labour relations and supervisory regulations regarding jobs and regulations are forthcoming.

The amendments are made in terms of the Pharmacy Act (1974 and refer to minimum standards and job descriptions for pharmacy technicians, pharmacy technical assistants and pharmacy general assistants.

In amending the “rules of good pharmacy practice”, the procurement, storage and distribution of “thermolabile” pharmaceutical products is set down in terms of cold chain storage; issues such as pharmacy courier services and even name tagging of pharmacy assistants set out and further regulations regarding the calculation of, dispensing fees outlined.

Pharmacies complain that they recently have been under severe strain recently in the light of new regulations on controlled pricing, with smaller pharmacies under extreme pressure to continue in operation against major retail chains opening dispensaries. The days of the “family chemist” are seeing their last, as owners become more involved in government’s stated policy to reduce the price of medicines.

Now introduced are issues on HIV testing carried out by many pharmacies countrywide. Associated bodies and stakeholders had until late December 2013 to submit public comment. The new regulations are awaited.

Medicine, food and education all affected….

A National Policy on Intellectual Property document has been published by the minister of trade and industry for broader public comment, cabinet approval having been already been obtained. The document is described as being very much a draft.

According to the policy’s objectives, it aims “to improve access to intellectual property-based essential goods and services, particularly education, health and food” and “introduce a public health perspective into intellectual property laws”.

Multitude of intellectual property issues

The document is also meant to inform legislative bodies on a multitude of intellectual property-related legislation matters, according to Macdonald Netshitenzhe, chief director of policy and legislation at the department of trade and industry (DTI), who has been responsible for the proposals.

In the background to the Bill, it states that the policies proposed are “meant to co-ordinate and streamline intellectual property legislation within South Africa.”

A 30-day public comment period on the policy closed on October 4 and Netshitenzhe says that the policy is meant to be a framework for discussion on intellectual property legislation within South Africa. He is clearly expecting dissenting views, which he says are welcomed.

A number of highly critical legal dissertations have already appeared on the web. One of the principal suggestions of the new proposals is to tighten up on patent criteria in order to avoid the granting of combinations of previously existing drugs, or finding a new uses for a medicines already on the market.

Patent application procedure changes

The policy also suggests allowing for patents to be opposed before and after they are granted. Currently in South Africa, patents can only be fought through a court challenge, and only after a patent has been granted.

Most notably, the policy also recommends a patent examination system. Currently, South Africa hosts a patent depository system, through which patents are granted so long as paperwork is submitted and fees paid, without the substance of the patent application being considered.

Médecins Sans Frontières, who are known to have been in contact with DTI on the policy matters, will be submitting comments, and, as Netshitenzhe explains, once the public comment period concludes, the amended document, including those comments, will be brought to Cabinet who may suggest further changes before giving its approval.

DTI says a final policy will only vetted by Parliament probably in the first portion of next year.Refer to articles in this categoryhttp://parlyreportsa.co.za//cabinetpresidential/carbon-tax-comes-under-attack-from-eskom-sasol-eiug/http://parlyreportsa.co.za//energy/new-air-quality-act-to-deal-with-major-polluters/http://parlyreportsa.co.za//energy/eskom-warns-on-costs-of-new-air-quality-rules/

At last getting there on HIV/AIDS…

On the subject of the department of health (DOH) budget vote, minister of health, Dr Aaron Motsoaledi, indicated to the parliamentary portfolio committee that DOH were getting on top of South Africa’s HIV/AIDS problem and he praised the doctors and nursing staff in government service for making this possible.

He said that South Africa faced the problems of increased life expectancy coupled with extra burden of having to reduce maternal and child mortality; reduce the burden of disease from HIV/AIDS and TB and, critically, improve the effectiveness of the health system.

HIV positive persons on therapy increases

He told parliamentarians that under a programme called NIMART, or Nurse Initiated Management of Antiretroviral Therapy, that health facilities providing antiretrovirals (ARVs) to HIV positive persons had increased from only 490 in February 2010 to 3,540. In the same vein, the number of nurses trained and certified to initiate ARV treatment in the absence of a doctor were increased from 250 in February 2010 to 23 000.

Under NIMART, the number of people on treatment went from 923 000 in February 2010 to 1,9 million to date – which meant a doubling the number on treatment. “This does not mean that any other epidemics in South Africa are less important, it simply emphasises that the central driver of morbidity and mortality in South Africa is largely HIV and AIDS and TB”, he said.

Groundbreaking single dose pill

Minister Motsoaledi also pointed out that DoH had recently introduced the “ground breaking” single dose combination or FDC therapy. For this over 7,000 health workers had to be trained but the windfall was that whereas it used to cost DoH R314.00 per patient per month to provide ARVs that now, with the single dose treatment, the cost is R89,00 per patient. “This means we can treat many more with the same money that needed to treat one person in 2009”, he said.

“I wish to take this opportunity to thank all the health workers for this sterling performance – especially the nurses without whom this numbers would have been impossible to achieve. The results we achieved from these endeavours are very sweet indeed.”

TB still the big enemy

He went on to tell parliamentarians that some four weeks ago, the Statistician-General had released StatsSA’s yearly figures on the causes of death from disease in South Africa. “They could only release at that stage the 2010 figures, but TB was found to be the number-one killer in the country – not surprising given the synergistic relationship between TB and HIV/AIDS.”

“Into this area of medicine, DOH has recently introduced what is known as GeneXpert technology, the last time any country having any new technology to diagnose TB being over fifty years ago. Before GeneXpert technology, it used to take us a whole week to diagnose TB”.

He said that DoH could now diagnose for TB and get a result in only two hours. This was critical when dealing with patients who have travelled miles or who had no money for transport to return, if they did at all.

Minister Motsoaledi said, “Since its unveiling on 23 March 2013, we have distributed 242 GeneXpert units around the country. This number constitutes 80% of all facilities we would like to cover.”

Worldwide help

He said, “ We had spent R117 million shared by the National Department of Health, the Global Fund and the Center for Disease Control in the USA, to achieve this 80% coverage. We have conducted 1,3 million tests using this technology since 2011 and this constitutes more than 50% of the total tests conducted in the whole world.”

He continued, “In five months’ time, we will achieve 100% coverage of all the district hospitals with this system and then we shall move to the big community health centres.”

“ The biggest of these machines, that can diagnose forty-eight patients at a time and I am pleased to say that two have placed, one at Ethekwini Municipality and the second in the Cape Metro at Greenpoint, both areas being the epicentres of TB at the moment.”

The following articles are archived on this subject:http://parlyreportsa.co.za//health/new-medicine-pricing-structures-out-for-comment/ http://parlyreportsa.co.za//uncategorized/state-acknowledges-responsibility-to-increase-health-staff/

Parliamentary oversight into the fight against HIV/AIDS…………….

Parliament has issued a statement that it has formed a joint committee on HIV and Aids to specifically focus on the pandemic, a “joint committee” being the coming together of members of both the National Council of Provinces and the National Assembly.

The statement issued said that the move “was born out of a decision by the sub-committee on the Review of Joint Rules and was an attempt to prevent the pandemic from spreading.”

The committee, said the statement, would act as an advisory, influential and consultative body and would monitor and evaluate the implementation of government’s strategy, policy and programmes on HIV and Aids.

Its activities will include introducing an HIV and Aids-related focus in parliamentary activities — including programming of debates, monitoring parliamentary oversight and ensuring that HIV/AIDS prevention and treatment are priorities on the national agenda.

The committee will also examine and evaluate the legal framework and make recommendations on existing and proposed legislation coming from the department of health.

SARS role at border posts being clarified …. In adopting the Border Management Authority (BMA) Bill, Parliament’s Portfolio Committee on Home Affairs agreed with a wording that at all future one-stop border […]